The US regulator has started a priority, six-month review of Takeda's dengue fever vaccine TAK-003 – tipped as a potential blockbuster product – making a decision likely in the first half o
uniQure and CSL have become the first pharma companies to get regulatory approval for a gene therapy for haemophilia B anywhere in the world, after the FDA cleared their Hemgenix therapy fo
At its second attempt, Provention Bio has secured FDA approval for teplizumab, as a treatment to delay late-stage type 1 diabetes (T1D) in at-risk individuals – becoming the first disease-m
The North Ireland Protocol has been a source of tension between the UK and EU since it came into force at the start of 2021 – and, according to one pharma company, the end of the so-called
NICE has recommended that three COVID-19 therapies can continue to be used to treat patients – Pfizer's Paxlovid, Roche's RoActemra, and Eli Lilly's Olumiant – but turned down another five
A pharma company’s core mission is to improve patient outcomes. This hinges on effectively influencing HCP clinical behaviour and driving disease education.